01.12.2014
Saxagliptin as initial therapy in treatment-naive Indian adults with type 2 diabetes mellitus inadequately controlled with diet and exercise alone: a randomized, double-blind, placebo-controlled, phase IIIb clinical study
Erschienen in: International Journal of Diabetes in Developing Countries | Ausgabe 4/2014
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The prevalence of type 2 diabetes mellitus (T2DM) is rapidly increasing in India. Additional antihyperglycemic treatment options are important for patients who cannot achieve glycemic control through diet and exercise. The dipeptidyl peptidase 4 (DPP-4) inhibitor saxagliptin is efficacious and well tolerated in Western patients with T2DM but has not been tested prospectively in a dedicated study in Indian patients. A multicenter, randomized, double-blind, placebo-controlled, parallel-group study was conducted in India to evaluate the efficacy and safety of saxagliptin. Treatment-naive adults with T2DM and glycated hemoglobin (HbA1c) between 7.0 % and 10.0 % at randomization were recruited. Patients were assigned 1:1 to receive saxagliptin 5 mg or matching placebo tablets once daily for 24 weeks. The primary efficacy endpoint was change from baseline to week 24 in HbA1c, using last observation carried forward methodology. Two hundred thirteen patients were randomized (saxagliptin, N = 107; placebo, N = 106). Adjusted mean absolute reductions in HbA1c from baseline to week 24 were significantly greater with saxagliptin (−0.51 % ;N = 104) versus placebo (−0.05 %; n = 105; difference for saxagliptin vs placebo, −0.46 %; SE, 0.14 %; 95 % CI, −0.73 %, −0.18 %; P = 0.0011). The incidence of adverse events was 47.7 % with saxagliptin and 45.3 % with placebo. No deaths, serious adverse events, or reported or confirmed hypoglycemic events occurred. Saxagliptin provided statistically and clinically significant improvement in HbA1c for Indian patients, similar to previous findings in Western study populations. Saxagliptin was well tolerated, with no previously unidentified safety findings, and had a safety profile comparable to placebo.
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